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NCT Number: NCT07360379

Comparing N-Acetylcysteine (NAC) Versus Alpha-Lipoic Acid (ALA) as Adjuncts for Postoperative Pain Management After Laparoscopic Appendectomy

Postoperative pain remains a major concern following laparoscopic appendectomy, despite advances in minimally invasive surgery and multimodal analgesia. Inadequate pain control delays recovery, prolongs hospital stay, and increases opioid consumption with associated adverse effects. Therefore, identifying safe adjunct therapies that enhance analgesia and reduce opioid requirements is an important clinical goal.

Oxidative stress and inflammation play a critical role in the development and maintenance of postoperative pain. Surgical trauma induces the generation of reactive oxygen species, which sensitize peripheral nociceptors and enhance central pain transmission.

Antioxidants capable of modulating oxidative stress and inflammatory pathways may therefore offer analgesic benefits beyond conventional analgesics.

N-Acetylcysteine (NAC), a glutathione precursor, has demonstrated anti-inflammatory and analgesic properties in both experimental and clinical settings. It reduces oxidative stress, improves microcirculation, and modulates nociceptive signaling.

Alpha-Lipoic Acid (ALA) is another potent antioxidant that acts as a cofactor in mitochondrial metabolism and has proven efficacy in neuropathic pain conditions. However, its role in acute postoperative pain has not been fully investigated.

To our knowledge, no clinical trial has directly compared NAC and ALA in the perioperative setting, and their effects following laparoscopic appendectomy remain unstudied. This randomized controlled trial aims to evaluate the efficacy and safety of NAC and ALA as adjuncts to standard analgesia, with the goal of estimating their effect on postoperative opioid consumption and pain intensity. The results will provide preliminary data to guide larger definitive studies.

Aim of the study The aim of this study is to evaluate and compare the efficacy and safety of N-acetylcysteine (NAC) and alpha-lipoic acid (ALA) as adjuncts to standard postoperative analgesia in patients undergoing laparoscopic appendectomy. Specifically, the study seeks to determine their effects on postoperative pain intensity, opioid consumption, and recovery profile in the early postoperative period.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-65 years, either sex
  • ASA physical status I-III
  • Undergoing laparoscopic appendectomy
  • Able to provide informed consent and take oral medications postoperatively

Exclusion criteria

  • Chronic opioid use or chronic pain disorder
  • Pregnancy or lactation
  • Hepatic or renal impairment
  • Known hypersensitivity to NAC or ALA
  • Complicated appendicitis requiring open surgery or ICU admission

Exclusion criteria

-

Treatment and study plan

N Acetyl Cysteine

Dietary Supplement

600 mg oral N-acetylcysteine 1-2 hours preoperatively

Alpha-Lipoic Acid (ALA)

Dietary Supplement

600 mg oral alpha-lipoic acid 1-2 hours preoperatively.

Placebo

Other

Matching placebo capsules given at identical intervals.

Primary outcomes

  1. Visual analogue scale (VAS)

    Time frame: At 2 hours, 6 hours, 12 hours , 24 hours , and 48 hours post-surgery

    Pain intensity: VAS at 2, 6, 12, 24, and 48 hours post-surgery (0 = no pain, 10 = worst pain)

Secondary outcomes

  1. Incidence of Nausea and vomiting

    Time frame: Assessed at 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours post-surgery

    assessed on a 3-point scale (0 = none, 1 = mild, 2 = severe)

  2. Rescue analgesia

    Time frame: in 24 and 48 hours post surgery

    time to first opioid request will be assessed

  3. Occurrence of Adverse effects

    Time frame: Occurrence of adverse effects will be assessed at baseline of the study and at 24 hours and 48 hours post surgery.

    Occurrence of adverse effects like dizziness, headache, rash, or gastrointestinal discomfort will be recorded and graded for severity.

  4. Total opioid use

    Time frame: at baseline of the study and at 24 hours and 48 hours post surgery

    Total opioid use will be assessed throughout the study period

Study contacts

Contact information is provided by the study sponsor or research team.

Eman Elmokadem, PhD of clinical pharmacy

CONTACT

[email protected]

+201006242110

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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